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20 Siora Surgicals Jobs

Senior Quality Assurance Executive

8-13 years

Sonipat

1 vacancy

Senior Quality Assurance Executive

Siora Surgicals

posted 5mon ago

Job Description

Education : UG: B Tech in Mechanical, BE Bio Medical, B. Pharma, B. Tech Medical Science
Key skills:
  • Thorough Knowledge of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.
Responsibility :
  • Create and maintain company quality documentation, such as manuals, procedures, etc.
  • Continuously improve QA processes and procedures.
  • Preparation of QA reports.
  • Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012.
Desired Candidate Profile:
  • Implementation and improvement in Quality Management System as per ISO 13485:2016.
  • Implementation & Formation of Standard Operating Procedure (SOP) & Protocols as per GMP.
  • Maintain complete documents of various departments like Site Master File, Device Master File with easy archival/retrieval.
  • Involve onsite into the calibration & Validation activities. Preparation of Calibration calendar and preventive maintenance.
  • Assist in preparation of Batch Manufacturing Record as per manufacturing and their review before release of the batch.
  • Giving line clearance before starting the New Batch.
  • Review and analysis of Environmental Monitoring plan to monitor environmental condition and hygiene of Personnel working in manufacturing areas and other controlled areas.

Employment Type: Full Time, Permanent

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What people at Siora Surgicals are saying

What Siora Surgicals employees are saying about work life

based on 29 employees
65%
90%
47%
100%
Flexible timing
Monday to Saturday
No travel
Day Shift
View more insights

Siora Surgicals Benefits

Health Insurance
Free Transport
Child care
Gymnasium
Cafeteria
Work From Home +6 more
View more benefits

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